The present disclosure relates to a hand held device for the application of one or more pedicle screws. More particularly, the present disclosure relates to a hand held device with at least one ultrasonic transducer element to identify a homogenous bone region for the application of the pedicle screws.
Current devices for placing pedicle screws have a number of limitations. Typically, in surgery, a surgeon will take a number of pre-operative fluoroscopic images. These fluoroscopic images will correctly show an area of interest and allow the surgeon to identify one or more areas for which to apply pedicle screws. Such fluoroscopic images or even radiographic images can provide a static picture of the region and show relevant structure of the bone. Such structures typically show voids, boundaries (between different types of bone) and fractures. The images also show homogenous bone regions. However, during the surgical procedure such treatment areas are difficult to visualize. Subsequent bone growth, and the change of positioning of the patient from when the images where taken and other features of the surgical area may obscure relevant structures of interest, and specifically the pedicle. Difficulties in such placement may result in or one or more detriments to the overall productivity of the surgical procedure.
The pedicle is a dense so-called “stem like” bone structure that projects from the posterior of the vertebra. There exist two such pedicles per vertebra that connect to other structures. The pedicle connects to other structures such as the vertebra arch and the lamina. Movement of the patient at surgery can alter the perception of the positioning of the bone features relative to an orientation of the images that were taken in a preoperative time frame. Often a surgeon must inject a marker to provide a reference point in the images.
Another approach uses computer imaging and/or x-ray imaging to provide some knowledge of the bony structure and the region of any possible voids, or the location of any fractures, or other structures. However, all of these imaging techniques are deficient because they provide static images without any real time feedback. All of these imaging techniques require a surgeon to examine the image, and then translate the positioning from the image to the corresponding bone region at the operative site. Once the desired location is found for a proper placement of a pedicle screw or other implant, the surgeon will often apply a titanium pedicle screw through the bone region to correct deformities and treat trauma.
Such screws may also be provided to immobilize the bone, and/or affix plates and rods to the spine. Although pedicle screws are most often used in the lumbar or lumbosacral spine, they can be also implanted in the thoracic spine, cervical spine and sacral vertebrae. The surgeon uses the pre-operative fluoroscopy or conventional x-ray images to determine the depth and angle for pedicle screw placement. A receiving channel is drilled and the pedicle screw is inserted. This practice of locating the region of interest can be time consuming and detract from the overall productivity of the operation. Moreover, as the surgical procedure necessitates that pedicle screws are introduced in relatively smaller sized bones, the positioning then becomes more difficult. Such positioning requires an experienced surgeon and time.
One such solution in the art is U.S. Pat. No. 6,849,047 to Goodwin (hereinafter “Goodwin”). Goodwin recites an apparatus for measuring one or more characteristics of bone using a transducer and a receiver. The apparatus is bulky and is rolled in on rollers to the operating room. The apparatus has an articulating arm. The apparatus further has a small test drill bit with a transducer. The transducer is passed in a lumen of the hollow test drill bit, and is used to inspect and monitor differences in acoustical impedance as the transducer is passed through a region in the bone. Goodwin is deficient as it monitors differences in acoustical impedance during drilling by the hollow test drill bit. Such a test application is deficient, may unduly weaken the bone and may lessen the integrity of the bone. Alternatively, Goodwin discloses that the transducer may be used to determine an initial starting location. However, once the initial starting location is determined, the transducer would have to be removed. This removal causes the surgeon to remove the apparatus, and then orient the drill on the determined site at a later time in order to commence drilling.
Accordingly, there is a need in the art for a real time positioning solution to determine proper pedicle screw placement. There is also a need for a solution that determines a region of interest and allows for simultaneously application of the pedicle screw. There is also a need for a device that does not require the surgeon to unduly consult pre-operative images, and then translate information from a static image to a dynamic site. There is a further need in the art for a hand held device that is comfortable to hold and that signals a surgeon that a homogeneous bone region has been located at the precise location of the homogeneous bone region. There is also a need in the art for a hand held and real time ultrasonic surgical device that can interrogate an area to determine the location of the homogenous bone region.